Abstract
BackgroundDiabetes is the third most common chronic condition in childhood and poor glycaemic control leads to serious short-term and life-limiting long-term complications. In addition to optimal medical management, it is widely recognised that psychosocial and educational factors play a key role in improving outcomes for young people with diabetes. Recent systematic reviews of psycho-educational interventions recognise the need for new methods to be developed in consultation with key stakeholders including patients, their families and the multidisciplinary diabetes healthcare team.Methods/designFollowing a development phase involving key stakeholders, a psychosocial intervention for use by paediatric diabetes staff and not requiring input from trained psychologists has been developed, incorporating a communication skills training programme for health professionals and a shared agenda-setting tool. The effectiveness of the intervention will be evaluated in a cluster-randomised controlled trial (RCT). The primary outcome, to be measured in children aged 4-15 years diagnosed with type 1 diabetes for at least one year, is the effect on glycaemic control (HbA1c) during the year after training of the healthcare team is completed. Secondary outcomes include quality of life for patients and carers and cost-effectiveness. Patient and carer preferences for service delivery will also be assessed. Twenty-six paediatric diabetes teams are participating in the trial, recruiting a total of 700 patients for evaluation of outcome measures. Half the participating teams will be randomised to receive the intervention at the beginning of the trial and remaining centres offered the training package at the end of the one year trial period.DiscussionThe primary aim of the trial is to determine whether a communication skills training intervention for specialist paediatric diabetes teams will improve clinical and psychological outcomes for young people with type 1 diabetes. Previous research indicates the effectiveness of specialist psychological interventions in achieving sustained improvements in glycaemic control. This trial will evaluate an intervention which does not require the involvement of trained psychologists, maximising the potential feasibility of delivery in a wider NHS context.Trial registrationCurrent Controlled Trials ISRCTN61568050.
Highlights
Diabetes is the third most common chronic condition in childhood and poor glycaemic control leads to serious short-term and life-limiting long-term complications
The primary aim of the trial is to determine whether a communication skills training intervention for specialist paediatric diabetes teams will improve clinical and psychological outcomes for young people with type 1 diabetes
This review described an ongoing UK evaluation of a familybased educational intervention in children and teenagers with diabetes [14,15]
Summary
Psychosocial factors are well-known to have a significant impact on the effective management of young people with diabetes in addition to medical management. The primary objective of the current trial is to determine whether a training package developed in consultation with healthcare professionals, patients and carers, for staff working in paediatric diabetes services to help them engage their patients with behaviour change, results in significant improvements in clinical outcome (HbA1c) for young people with type 1 diabetes. Clinical psychology services are currently inadequate in paediatric diabetes care: such an approach allows these limited resources to be directed where most needed, maximising the potential feasibility of intervention delivery across the NHS. Additional aims of the study are to demonstrate both feasibility in terms of roll-out across the NHS and cost-effectiveness, given that the intervention is the first of its kind not requiring specialist input from clinical psychology services, which are currently limited in paediatric diabetes care
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